Eli Ezer

Primary DI
00851158007386
Brand
Eli Ezer
Company
U.S. OPHTHALMIC, L.L.C.
Model
EZ-OPH-1800/LL
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLJOphthalmoscope, Battery-Powered
HLLMonitor, Eye Movement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2
HLLMonitor, Eye MovementOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K05259900066 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25ASuzhou 66 Vision Tech Co., Ltd.2006-11-07HLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851158007386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851158007386008511580073868511580073860851158007386

GMDN Terms#

Term, Definition table
TermDefinition
Direct ophthalmoscope, battery-poweredA battery-powered, hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of a built-in light source that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single view hole, and a dial containing several lenses of different powers that can be alternated by the examiner while viewing. It produces an upright, or unreversed, image of about 15 times magnification. Batteries are housed in the instrument’s handle; supplemental devices (e.g., spare light bulbs) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
166760392
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038195564EZ-TRI-3600EZ-TRI-36002025-02-19
00850038195557LuxVsionLDR-7800LDR-78002024-04-08
00851158007805Eli EzerEDR-H2024-04-08
00851158007836Eli EzerEDR-9000 A2024-04-08
00850038195335Eli EzerEZ-OPH-3600-Halogen-Lamp2024-04-03
00850038195342Eli EzerEZ-OPH-3600- Led Lamp2024-04-03
00851158007621Eli EzerESL-Emerald-12024-01-25
00851158007638Eli EzerESL-Emerald-82024-01-25
00851158007645Eli EzerESL-Emerald-182024-01-25
00851158007652Eli EzerESL-Emerald-122024-01-25
00851158007669Eli EzerESL-Emerald-262024-01-25
00851158007683Eli EzerESL-Emerald-TN2024-01-25
00851158007003LuxVisionSL-11002016-08-16
00851158007010LuxVisionSL-14002016-08-16
00851158007027LuxVisionSL-20002016-08-16
00851158007034LuxVisionSL-7002016-08-16
00851158007041LuxVisionSL-8802016-08-16
00851158007126GilrasGR-7/LL2016-08-17
00851158007133GilrasGR-7/HL2016-08-17
00851158007140GilrasGR-7 2X/HL2016-08-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00192896009509HEINE - BETA R HANDLESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009516HEINE - LITHIUM ION BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009523HEINE MPACK MINI SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009530HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009547HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009554HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009561HEINE HC 50 CONNECTING CORDSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009578HEINE MPACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009585HEINE MPACK COMPLETESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009592HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC.HLJ2018-08-24
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